Fluid monitoring device with disposable inner liner with sensor integration

ABSTRACT

A fluid monitoring assembly includes a segment of tubing having a wall defining a lumen through which the fluid passes and a sensor at least partially embedded within a wall of the tubing. The assembly includes a housing having first and second portions connected to one another at a hinge, the housing defining an interior portion configured to hold the segment of tubing and the sensor. The housing may be opened and closed as needed using a fastener.

RELATED APPLICATION

This application claims priority to U.S. Provisional Patent ApplicationNo. 61/897,531 filed on Oct. 30, 2013, which is hereby incorporated byreference in its entirety. Priority is claimed pursuant to 35 U.S.C. §119.

FIELD OF THE INVENTION

The field of the invention generally relates to fluid monitoring devicesand, in particular segments of conduit or tubing that incorporate sensorfunctionality. More specifically, the invention pertains to connectorsor interfaces used by pharmaceutical and biological applications orother hygienic process industries involving silicone tubing or otherconduits that include sensors therein.

BACKGROUND

Many commercial products are produced using chemical as well asbiological processes. Pharmaceuticals, for example, are produced incommercial quantities using scaled-up reactors and other equipment.So-called biologics are drugs or other compounds that are produced orisolated from living entities such as cells or tissue. Biologics can becomposed of proteins, nucleic acids, or complex combinations of thesesubstances. They may even include living entities such as cells. Inorder to produce biologics on a commercial scale, sophisticated andexpensive equipment is needed. In both pharmaceutical and biologics, forexample, various processes need to occur before the final product isobtained. For example, in the case of biologics, cells may be grown in agrowth chamber or the like and nutrients may need to be carefullymodulated into the growth chamber. Waste products produced by cells mayalso have to be removed on a controlled basis from the fermentationchamber. As another example, biologic products produced by living cellsor other organisms may need to be extracted and concentrated. Thisprocess may involve a variety of filtration and separation techniques.

Because there are a number of individual processes required to beproduce the final product, various reactants, solutions, and washes areoften pumped or otherwise transported to various subsystems usingconduits and associated valves. These systems may be quite cumbersomeand organizationally complex due to the large numbers of conduits,valves, sensors, and the like that may be needed in such systems. Notonly are these systems visually complex (e.g., resembling spaghetti)they also include many components that are required to be sterilizedbetween uses to avoid cross-contamination issues. Indeed, the case ofdrug and biologic preparation, the Federal Food and Drug Administration(FDA) is becoming increasingly strict on cleaning, sterilization orbio-burden reduction procedures that are required for drug andpharmaceutical preparations. This is particularly of a concern becausemany of these products are produced in batches which would requirerepeated cleaning, sterilization or bio-burden reduction activities on avariety of components.

During the manufacturing process of pharmaceuticals and biologics thereoften is a need to incorporate sensors into the manufacturing process sothat process variables are monitored. For example, the process variablesthat need to be monitored may include temperature, pressure, pH,conductivity, and the like. In conventional setups, sensors are placeddirectly along one or more points of the production process whereby thesensors themselves are inserted into the production stream where thesensor makes direct contact with the reactant or product stream. Directcontact of the sensor with the reactant or the product stream may resultin potential contamination issues. Further, in conventionalmanufacturing processes, the sensors may need to be changed, forexample, due to a malfunction or because the product being manufacturedrequires a different sensor. In these examples, it can be a timeconsuming and expensive process to replace these sensors and alsoensuring that reactants or products remain uncontaminated.

SciLog BioProcessing Systems, for example, produces a line of single usedisposable sensors for use with bioprocessing application. These includepressure sensors, temperature sensors, and conductivity sensors. In theSciLog sensors, however, portions of the sensing elements come intocontact with the fluid passing through the unit. Moreover, the entireunit is thrown away including the tubing, sensor, and associatedhousing. U.S. Pat. No. 7,788,047 discloses a disposable, pre-calibrated,pre-validated sensor for use in bioprocessing applications. In the '047patent electrodes pins (204) are in contact with fluid passing along theinterior of the conduit (102). The entire assembly containing theconduit and sensor is designed to be thrown away.

SUMMARY

According to one embodiment of the invention, a fluid monitoringassembly includes a segment of tubing having a wall defining a lumenthrough which the fluid passes. The assembly further includes a sensorat least partially embedded within a wall of the tubing. The assemblyincludes a housing having first and second portions connected to oneanother at a hinge, the housing defining an interior portion configuredto hold the segment of tubing and the sensor. In one embodiment, thetubing is silicone. For example, the tubing may include UV-curedsilicone or in other embodiments, thermally cured silicone. The sensorsmay include a pressure sensor or a conductivity sensor. The housing maybe opened and closed via a fastener.

According to another embodiment, a fluid pressure assembly includes asegment of tubing having a wall defining a lumen through which the fluidpasses. The assembly includes a housing having first and second portionsconnected to one another at a hinge, the housing defining an interiorportion configured to hold the segment of tubing. The assembly includesa pressure sensor having a pressure sensing end in contact with aportion of the wall, wherein fluid pressure within the lumen istransmitted through the wall to the pressure sensing end. In oneembodiment, the tubing may be made from silicone. The silicone may bethermally cured or UV-cured.

According to another embodiment, a method of changing a fluid monitoringassembly that includes a segment of tubing having a wall defining alumen through which the fluid passes, a sensor embedded within a wall ofthe tubing, and a housing having first and second portions connected toone another at a hinge, the housing defining an interior portionconfigured to hold the segment of tubing and the sensor. The methodincludes opening the housing, removing the tubing, inserting a secondtubing containing a sensor into the housing; and closing the housing.The sensor in the second tubing may be the same or different sensor.

In another embodiment, a method of forming a fluid monitoring assemblyincludes inserting a sensor into a cavity of a mold; injecting a liquidsilicone rubber into the mold cavity, wherein the liquid silicone rubberat least partially surrounds a portion of the sensor; and applying UVradiation to the liquid silicone rubber to cure the silicone.

In another embodiment, a fluid monitoring assembly includes a segment oftubing having a wall defining a lumen through which the fluid passes.The assembly includes a housing having first and second portionsconnected to one another at a hinge, the housing defining an interiorportion configured to hold the segment of tubing; and a conductivitysensor at least partially embedded in the wall of the segment of tubing,wherein the conductivity sensor further comprises a plurality ofelectrodes extending through the wall and into the lumen.

In another embodiment, a fluid assembly includes a segment of tubinghaving a wall defining a lumen through which the fluid passes; a housinghaving first and second portions defining an interior portion configuredto hold the segment of tubing; at least one valve disposed on thehousing and configured to pinch the segment of tubing; and one or moresensors at least partially embedded in the wall of the segment oftubing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a side view of a fluid monitoring assembly accordingto one embodiment.

FIG. 1B illustrates a top down view of the fluid monitoring assembly ofFIG. 1A.

FIG. 1C illustrates a cross-sectional view of the fluid monitoringassembly taken along the line A-A of FIG. 1A.

FIG. 1D illustrates a side view of the fluid monitoring assembly withthe housing being partially transparent to illustrate the pH sensorcontained therein.

FIG. 2A illustrates a side view of a silicone liner (e.g., tubing)containing a conductivity sensor according to one embodiment.

FIG. 2B illustrates a top view of the silicone liner of FIG. 2A.

FIG. 2C illustrates an end view of the silicone liner of FIG. 2A.

FIG. 2D illustrates a perspective view of the silicone liner of FIG. 2A.

FIG. 2E illustrates a side view of a fluid monitoring assembly accordingto one embodiment.

FIG. 2F illustrates an end view of the fluid monitoring assembly of FIG.2E.

FIG. 2G illustrates a cross-sectional view of the fluid monitoringassembly of FIG. 2E taken along the line A-A.

FIG. 2H illustrates a top view of the fluid monitoring assembly of FIG.2A.

FIG. 2I illustrates a perspective view of the fluid monitoring assemblyof FIG. 2A.

FIG. 2J illustrates a partially cut-way view of the fluid monitoringassembly. A portion of one half of the housing is cut away to illustratethe silicone liner and other features.

FIG. 3 illustrates a mold according to one embodiment used tomanufacture the integrated silicone liner and sensor of the fluidmonitoring assembly illustrated in FIGS. 2A-2J.

FIG. 4A illustrates a side view of a fluid monitoring assembly thatincludes a pressure sensor.

FIG. 4B illustrates an opposing side view of a fluid monitoring assemblythat includes a pressure sensor.

FIG. 4C illustrates a side view of a silicone liner used in the fluidmonitoring assembly of FIG. 4A.

FIG. 4D illustrates one alternative of a silicone liner used in thefluid monitoring assembly of FIG. 4A.

FIG. 4E illustrates another alternative of a silicone liner used in thefluid monitoring assembly of FIG. 4A.

FIG. 5A illustrates a side view of an alternative fluid managementassembly that incorporates fluid monitoring.

FIG. 5B is a cross-sectional view taken along the line B-B of FIG. 5A.

FIG. 5C is a cross-sectional view taken along the line C-C of FIG. 5A.

FIG. 5D illustrates a plan view of the fluid management assembly.

FIG. 5E illustrates a perspective view of a fluid management assembly.

FIG. 6A illustrates a liner used in the fluid management assembly ofFIGS. 5A-5E

FIG. 6B illustrates a cross-sectional view taken along the line B-B ofFIG. 6A.

FIG. 6C illustrates a cross-sectional view taken along the line C-C ofFIG. 6A.

FIG. 6D illustrates a plan view of the liner.

FIG. 7 illustrates another embodiment of a fluid management assembly.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

FIGS. 1A-1D illustrate one embodiment of a fluid monitoring assembly 10according to one embodiment. The fluid monitoring assembly 10 isdesigned as a single-use, disposable device. The fluid monitoringassembly 10 includes a housing 12 that contains a pH sensor 14. Thehousing 12 includes a conduit segment 13 having a lumen 15 (best seen inFIG. 1C) extending within the conduit segment 13 which fluid passesthrough. The conduit segment 13 terminates at opposing ends with flanges16, 18. The housing 12 illustrated in FIG. 1C is unitary body in whichthe flanges 16, 18 are integrated on opposing ends of the conduitsegment 13. The conduit segment 13 may be formed as a cylindrical tubingalthough other geometries are contemplated. Flanges 16, 18 are designedto mate with corresponding flanges (not shown) contained in fluid lineof a manufacturing process. In this regard, the fluid monitoringassembly 10 may be inserted at desired locations so that the pH sensor14 may be easily added or removed as necessary. Typically, therespective facing surfaces of the flanges 16, 18 (and opposing ends) areheld together via a clamp or the like. An o-ring or other seal (notshown) may be provided in a groove 20 contained in the flanges 16, 18for sealing purposes (as seen in FIG. 1B).

In other alternative embodiments, the flanges 16, 18 may be omitted andthe housing 12 may extend laterally beyond the portion containing thesensor 14 without any mating surface or flange type structure.

The housing 12 further includes a mounting section 22 that is orientedgenerally perpendicular to the long axis of the conduit segment 13 andincludes a bore 24 (FIG. 1C) that is configured to receive the pH sensor14. In this embodiment, a portion of the bore 24 is threaded 26 suchthat corresponding threads 28 contained on the pH sensor 14 interfacetherewith. The pH sensor 14 includes a shank portion 30 that terminatesin a sensing end 32. The sensing end 32 of the pH sensor 14 extends intothe lumen 15 so as to expose the sensing end 32 passing fluid. A pair ofo-rings 34, 36 are disposed about the shank portion 30 of the pH sensor14 and serve to seal the pH sensor 14 relative to the housing 12.

In this embodiment, the pH sensor 14 has a reduced length which istypically less than around 3 inches for use with a housing 12 havinglumen 15 internal diameter of 1.0 inches. Of course, other sizedhousings 12 may are contemplated (e.g., 3.4 inch I.D.). The pH sensor 14can be screwed into the mounting section 22 of the housing 12.Optionally, one or more sealants, adhesives, glues may be used inaddition to the o-rings 34, 36 to aid is sealing the pH sensor 14 withinthe housing 12. In one preferred embodiment, the housing 12 is typicallymade from a polymer material such as plastic materials. Materialsinclude standard thermoplastics and polyolefins such as polyethylene(PE) and polypropylene (PP). The housing 12 may also be formed fromfluoropolymers such as polyvinylidene fluoride (PVDF) or perfluoroalkoxy(PFA), polytetrafluoroethylene (PTFE), polycarbonate (which may be morethermally resistant), polysulfone (PSU), and the like. The housing 12may also be made out of a metal. The pH sensor 14 includes an end orconnector 38 located on an exposed portion of the pH sensor 14 which canbe connected via wires (or in other embodiments wirelessly) to a pHreader (not shown).

FIGS. 2A-2J illustrate a fluid monitoring assembly 40 according toanother embodiment. This embodiment pertains to a fluid monitoringassembly 40 that includes a conductivity sensor 42 that is embedded orpotted within a liner 44 can then be loaded into a two-part housing 46(seen in FIGS. 2E-2J). The liner 44 may, in one preferred embodiment, bemade from silicone although other materials may be used. In thisembodiment, the silicone liner 44 along with the embedded conductivitysensor 42 can be made disposable while the housing 46 can be re-usedwith another new or un-used silicone liner 44 with the conductivitysensor 42 contained therein. FIGS. 2A-2D illustrate a silicone liner 44according to one embodiment. The silicone liner 44 includes a conduitsegment 48 defining a wall and having a lumen 50 (best seen in FIG. 2C)extending within the conduit segment 48 which fluid passes through(e.g., a segment of silicone tubing). The conduit segment 48 terminatesat opposing ends with silicone flanges 52, 54. The silicone flanges 52,54 are dimensioned to reside within corresponding flanges (describedbelow) in the two-part housing 46. The silicone liner 44 also includes aconductivity sensor 42 that is embedded or otherwise potted into aportion of the wall of the conduit segment 48. As best seen in FIGS. 2Aand 2D, an overmolded portion 56 that extends outwardly from the wall ofthe conduit segment 48 contains the conductivity sensor 42.Substantially all or a portion of the conductivity sensor 42 is embeddedwithin the silicone liner 44. A connector 58 is exposed outside of theovermolded portion 56 and is used to connect the conductivity sensor 42via cabling, wiring, or the like. The conductivity sensor 42 may be acommercially available sensor or probe that is integrated into thesilicone liner 44. Alternatively, the conductivity sensor 42 may includea variety of different kinds and makes of conductivity sensors. Forexample, the conductivity sensor 42 may include two, four, or adifferent number of electrodes. The electrodes may be made from variousmaterials such as, for instance, gold or stainless steel.

As best seen in FIGS. 2A and 2C, the conductivity sensor 42 includes oneor more electrodes 60 that project or extend inwardly from the wall ofthe conduit segment 48 so that the one or more electrodes 60 are exposedto the lumen 50 where the fluid resides. During the manufacturingprocess, portions (e.g., the base) of the one or more electrodes 60 aresealed against the molded silicone. This arrangement leaves portions ofthe electrodes 60 (e.g., tips or ends) that are exposed to the productpassing through the lumen 50.

FIGS. 2I-2J illustrate the fluid monitoring assembly 40 after thesilicone liner 44 that contains the conductivity sensor 42 has beeninserted into the two-part housing 46. The two-part housing 46 includesa first half 46 a and a second half 46 b that are connected together viaa hinge 62. The hinge 62 may be constructed, for example, as a rod orpost that is contained within an aperture or bore that permits the firsthalf 46 a and second half 46 b to pivot from a closed state to an openstate so that the silicone liner 44 containing the conductivity sensor42 can be easily removed and replaced. A fastener 64 such as a lockingknob and associated locking arm 65 can be used to fixedly hold thetwo-part housing 46 in the closed state. Of course, other types offasteners 64 can be used. These include screws, nuts, clamps, bands,ties, and the like. Multiple fasteners 64 may also be used. As best seenin FIG. 2G, the two-part housing 46 includes flanges 66, 68 that aresized to contain the corresponding silicone flanges 52, 54 of thesilicone liner 44. In an alternative embodiment, the flanges 52, 54 ofthe liner 44 may be omitted along with the flanges 66, 68 of the housing46. The housing 46 may thus extend laterally beyond the location of theconductivity sensor 42 and not terminate in a mating structure orflange-like surface. The housing 56 may continue on in any number ofgeometrical configurations. For example, the 56 housing may continue asa straight segment, a curved segment, elbow or the like.

FIG. 2G illustrates a cross-sectional view of the fluid monitoringassembly 40 taken along the line A-A of FIG. 2F. FIG. 2F shows how thesilicone liner 44 remains nested within the two-part housing 46. Thetwo-part housing 46 contains the conduit segment 48 as well as theovermolded portion 56 that contains the conductivity sensor 42. Thetwo-part housing 46 provides an opening 70 (FIG. 2I) so that theconnector 58 is exposed to the exterior environment and can be securedto appropriate cabling, wiring, or the like. In this embodiment, thetwo-part housing 46 is preferably made of a metal such as stainlesssteel. However, in alternative embodiments, the two-part housing 46 maybe made from plastic or polymer materials. In this regard, the two-parthousing 46 may be re-used while the silicone liner 44 and theconductivity sensor 42 may be disposable. Like the prior embodiment, thesize of the fluid monitoring assembly 40 may vary. For example, withoutlimiting the invention, the ID of the silicone liner 44 may be 1 inchalthough other sizes may also be used.

In order to create the silicone liner 44 with the embedded or pottedconductivity sensor 42, a UV-curable Liquid Silicone Rubber (LSR) isused in one particular embodiment. For example, SILOPREN available fromMomentive Performance Materials Inc. (Albany, N.Y.) is a UV cured LSRthat may be used to form the silicone liner 44. SILOPREN is atwo-component LSR what uses a mixing ratio of 100:2. Another example ofa UV cured silicone is ADDISIL available from Momentive PerformanceMaterials Inc. (Albany, N.Y.) which offers high cure speed at roomtemperatures. ADDISIL silicone rubber is a two component solution thatuses a mixing ratio of 100:0.5 (Rubber Base:Catalyst). The benefits ofusing a UV curable LSR are numerous. First, there is no heating of thematerials as is required in conventional silicone curing techniques.Thus, the silicone liner 44 may be formed at substantially roomtemperatures. If the silicone liner 44 described herein were to beformed with conventional thermally-cured silicone, embedded conductivitysensor 42 would melt, deform, or otherwise fail during the curingprocess. Here, using the UV curing process, the conductivity sensor 42remains unaffected by the curing process. Because no heating isrequired, the process also has low energy consumption. Further, the UVcuring process uses less equipment and can increase throughput asheating up and cool-down tend to consume a considerable amount of time.Another example of a UV curable silicone is the SEMICOSIL UV productmade by Wacker Chemie AG (Munich, Germany).

Standard liquid silicone rubbers are processed in molds generally attemperatures between 180 and 200° C. UV-cured LSR parts can be made withtransparent molds cured by UV light as explained herein. UV curingtypically occurs at ambient or slightly above ambient temperatures(e.g., 25-40° C.). For thick parts, UV curing is advantageous becausethe product may cross-link much more quickly than with thermal curingbecause the low thermal conductivity of the silicone rubber is not afactor. Another advantage of UV curing is that the curing is initiatedwhen the light is first turned on rather than on first contact with theheated mold. This difference eliminates the problem of silicone rubberscorching. Related to this, the liquid silicone (or other polymer) canbe pumped into the mold relatively slowly and at low pressures.

FIG. 3 illustrates a method of making the silicone liner 44 with theembedded conductivity sensor 42. In the method, a mold 72 is provided inwhich the conductivity sensor 42 is placed along with a core 74 thatdefines the lumen 50. Alternatively, the core 74 may be omitted and theportion defining the lumen 50 may be defined in the mold itself. TheUV-curable LSR is then loaded into the mold 72 as indicated by arrow A.The UV-curable LSR is then subject to irradiation with UV light bysource(s) 76 to cure the LSR into a solid form. After curing, thesilicone liner 44 is embedded or potted within the wall of the siliconeliner 44.

In other embodiments, it may be possible to mold the conductivity sensor42 into a silicone liner 44 that is heat-cured rather than UV-cured. Forexample, the conductivity sensor 42 may be made from a high temperatureplastic material (resistant to high temperatures) such that the thermalcuring may be used to cure the silicone liner 44.

While FIGS. 2A-2J illustrate a fluid monitoring assembly 40 thatincludes a conductivity sensor 42, it should be understood thatalternative sensors may be incorporated in this embodiment. For example,the sensor could be a pH sensor, a temperature sensor, a pressuresensor, turbidity sensor, or the like. In some alternative embodiments,the active region of the sensor may not need to come into direct contactwith the fluid contained in with the silicone liner 44. For example, ifthe sensor is optical-based sensor it may be able to transmit a signalthrough a thin portion of the liner that can be detected on the opposingside. In such an example, there is no need for direct contact betweenthe sensor and the fluid that passes through the silicone liner 44.

FIGS. 4A-4E illustrate one embodiment of a fluid monitoring assembly 80according to another embodiment. This embodiment pertains to a fluidmonitoring assembly 80 that includes a pressure sensor 82 that has apressure sensing end 83 that is in contact with a wall 85 of thesilicone liner 84. The pressure sensor 82 and the silicone liner 84 areheld in place with a two-part housing 86. In this embodiment, thesilicone liner 84 can be made disposable while the housing 86 can bere-used with another new or un-used silicone liner 84. The pressuresensor 82 may also be reusable. The pressure sensor 82 may be made ofany number of materials. In some alternative embodiments, a portion ofthe pressure sensor 82 may be from a UV curable material though this isnot required. The housing 86 may be divided into two halves 86 a, 86 bthat can be selectively opened and closed so that the silicone liner 84may be replaced. The two halves 86 a, 86 b are moveable via the hinge 88as seen in FIG. 4B. A fastener 90 such as a locking knob and associatedlocking arm 92 can be used to fixedly hold the two-part housing 86 inthe closed state. As best seen in FIG. 4A, the two-part housing 86includes flanges 94, 96 that are sized to contain the correspondingsilicone flanges 98, 100 (best seen in FIG. 4C) of the silicone liner44.

In an alternative embodiment, the flanges 98, 100 of the liner 44 may beomitted along with the flanges 94, 96 of the housing 86. The housing 86may thus extend laterally beyond the location of the pressure sensor 82and not terminate in a mating structure or flange-like surface. Thehousing 86 may continue on in any number of geometrical configurations.For example, the 86 housing may continue as a straight segment, a curvedsegment, elbow or the like.

FIG. 4C illustrates the silicone liner 84. The silicone liner 84, likethe prior embodiment, includes a wall 85 that defines a lumen 102through which fluid passes (e.g., a segment of silicone tubing). Thewall 85 includes a reduced thickness portion 85 a seen in FIG. 4C whichis interposed between the lumen 102 and the pressure sensing end 83 ofthe pressure sensor 82. During operation, pressure from the fluid withinthe lumen 102 is transferred via the reduced thickness portion 85 a tothe pressure sensing end 83. In this embodiment, the pressure of thefluid in the lumen 102 is measured indirectly via the wall 85 of thesilicone liner 84—there is no direct contact of fluid against thepressure sensor 82. Fluid pressure within the lumen is transmittedthrough the wall 85 to the pressure sensing end 83 of the pressuresensor 82.

This is advantageous because there is no risk of contamination fromcontact with the pressure sensor 82. Further, the pressure sensor 82 mayalso be re-usable with another silicone liner 84. As seen in FIG. 4C, arecess 104 is formed in the wall 85 that receives the pressure sensingend 83 of the pressure sensor 82.

The silicone liner 84 may be made using a heat-cured or UV curedprocess. In fact, in other embodiments, the liner 84 may be formed froma material other than silicone. Other configurations of the interfacebetween the wall 85 of the silicone liner 84 and the pressure sensor 82are contemplated. FIG. 4D illustrates a different embodiment wherein anipple 106 projects from the wall 85 and interfaces with the pressuresensing end 83 of the pressure sensor 82. FIG. 4E illustrates analternative embodiment wherein a button or region of increased thickness108 in the wall 85 interfaces with the pressure sensing end 83 of thepressure sensor 85. The invention is not limited to the type of pressuresensor 82 that is used. Referring back to FIG. 4A, a commerciallyavailable Endress+Hauser pressure sensor 82 (Ceraphant T) is illustratedbeing used although it should be understood that other pressure sensors82 may be used. The pressure sensor 82 may include any type of pressuresensor such as those that are diaphragm-based, strain-gauge based,semiconductor based, fluid-based, and the like. As seen in FIG. 4A, thepressure sensor 82 includes threads 110 that engage correspondingthreads 112 in the two-part housing 86.

The two-part housing 86 is opened and closed as explained previously inthe context of the embodiment of FIGS. 2A-2J. In particular, thefastener 90 is tightened or loosened to secure the two parts of thehousing 86 a, 86 b together. The two-part housing 86 is preferablyconstructed of a metal such as stainless steel. However, in alternativeembodiments, the two-part housing 46 may be made from plastic materials.Further, as noted above, other types of fasteners may be used. Theseinclude screws, nuts, clamps, bands, ties, and the like.

FIGS. 5A-5E and 6A-6D illustrate another embodiment of a fluidmanagement assembly 120. This embodiment incorporates one or moresensors 122, 124 into an assembly that also contains one or more valves126. With reference to FIGS. 5A-5E, the fluid management assembly 120includes a housing 128 that is formed from a first portion 128 a and asecond portion 128 b that may be brought or assembled together to form asingle housing 128. In the embodiment of FIGS. 5A-5E, the first andsecond portions 128 a, 128 b are connected via a hinge 130. The housing128 can thus be opened and closed so that an internal liner 132 can beselectively placed against facing surfaces of the first and secondportions 128 a, 128 b. The facing surfaces of the first and secondportions 128 a, 128 b contain corresponding hemispherical-shaped groovesthat, when brought together as seen in FIG. 5A, encapsulate the liner132. FIGS. 6A-6D illustrate one embodiment of the liner 132. The housing128 may be formed from a metal (e.g., stainless steel) or polymermaterial (e.g., plastic material).

The first and second portions 128 a, 128 b are held in a closed statevia fasteners 134, 136. Fasteners 134, 136 may include a knob, screw,clamp, or the like. Two such fasteners 134, 136 are illustrated althougha single fastener (or more fasteners) may be used in other embodiments.FIGS. 5A, 5D, and 5E illustrate three valves 126 that are secured to thehousing 128 and are used to selectively pinch or otherwise close theliner 132 in a selective manner. The valves 126 may be manual valves orautomatic valves (e.g., pneumatically activated or servo-typeactuators). The valves 126 generally operate by having a stem or thelike that can extend or retract as needed to prevent or enable fluidflow through the liner 132. These valves 126 can be located at a commonconduit or branch pathway so that flow can be directed as desired. Whilethree (3) such valves 126 are illustrated, more or less may be used.

In the embodiment of FIGS. 5A-5E, two different types of sensors 122,124 are included in the assembly 120. The first sensor 122 includes aconductivity sensor 122 such as the type illustrated in FIGS. 2A-2J. Inparticular, the conductivity sensor 122 is at least partially embeddedor potted within a wall of the liner 132. The conductivity sensor 122illustrated in FIG. 5B includes electrodes 138 that are in conduct withproduct that passes through the lumen 140 of the liner 132. In someembodiments, the liner 132 may be formed from a UV-curable silicone.Alternatively, it may be possible to integrate the conductivity sensor122 using a heat-curable silicone. In some embodiments, the liner 132may be made of another polymer material besides silicone. FIG. 5Cillustrates a second sensor 124 that is the form of a pressure sensor124. The pressure sensing end 142 of the pressure sensor 124 is incontact with a portion of the wall of the liner 132, wherein fluidpressure within the lumen 140 is transmitted through the wall to thepressure sensing end 142. The portion of the wall of the liner 132 thatis contact with the pressure sensing end 142 may include a reducedthickness portion like that shown in FIG. 5C or it may include a nippleor thickened region like the embodiments of FIGS. 4D and 4E.

FIGS. 6A-6D illustrate the liner 132 with the conductivity sensor 122embedded therein. The contact region of the wall of the liner 132 thatis in contact with the pressure sensing end 142 of the pressure sensor124 can best be seen in FIG. 6C. In this embodiment, the liner 132terminates at flanges 144 a, 144 b, 144 c, 144 d, and 144 e. Theseflanges 144 a, 144 b, 144 c, 144 d, and 144 e can then be used toconnect to various other components/devices to the fluid managementassembly 120. In some embodiments, the flanges 144 a, 144 b, 144 c, 144d, and 144 e are not encapsulated by corresponding flanges in thehousing portions. In an alternative configuration, the housing 128 mayintegrate corresponding half flanges to contain the flanges 144 a, 144b, 144 c, 144 d, and 144 e. In still another alternative embodiment,neither the liner 132 nor the housing 128 may terminate in anyflange-like structure. Rather, the housing 128 may extend laterally tocover extension of the liner 312. The housing 128, as explained herein,may take a number of different geometric configurations (e.g., elbows,bends, and straight segments).

FIG. 7 illustrates another embodiment of a fluid management assembly 150according to one embodiment. In this embodiment, the fluid managementassembly 150 contains one or more manually operated valves. The fluidmanagement contains a liner 152 that is similar those previouslydiscussed herein. The liner 152 is made from a polymer material such assilicone and includes a central lumen 154 that is defined by a wallstructure 156. The liner 152 terminates at optional flanges 158 a, 158 bthat can then be used to connect to other components/devices to thefluid management assembly 150. The fluid management assembly 150includes a housing 160 that encapsulates the liner 152. FIG. 7illustrates one half of the housing 160. It should be understood thatthe housing 160 may include a two component structure such as thatillustrated in the embodiment of FIGS. 5A-5E where two halves of thehousing 160 can be opened and closed via hinge(s) and closed using oneor more fasteners (not shown). The housing 160 may be made from thepolymeric or metallic material.

As seen in FIG. 7, the fluid management assembly 150 includes an on/offvalve 162 in addition to a manually operated control valve 164. Theon/off valve 162 is a toggle-type valve that has an “on” position and an“off” position. The on/off valve 162 operates by depressing (or notdepressing) a plunger 165 within the fluid management assembly 150 topinch or close flow within the liner 152. The manually operated controlvalve 164 also includes a plunger 166 that moves generally perpendicularto the axis of the liner 152 in response to a knob 168 that is turned.Turning of the knob 168 advances or retracts the plunger 166 so that theinternal diameter of the liner 152 is adjusted to control the flow offluid therein. As the plunger 166 compresses the liner 152 flow withinthe liner 152 is reduced. Conversely, as the plunger 166 is retracted,more fluid is able to flow within the liner 152.

Also illustrated in FIG. 7 is an optional pressure sensor 170 that isintegrated into the fluid management assembly 150. The pressure sensor170 extends through the housing 160 and places a pressure sending end172 in contact with an outer surface of the liner 152. The pressuresensor 170 is able to detect and sense pressure of fluid within theliner 152 without direct contact with the fluid in one embodiment. Asseen in FIG. 7, the pressure sensor 170 is an analog sensor though itshould not be so limited. Any type of pressure sensor 170 includingdigital sensors may be used. In addition, at the location where thepressure sensing end 172 contacts the liner 152, the liner 152 mayoptionally include a thinned out or narrow wall portion.

In one alternative embodiment, a RF identification tag or chip (RFID)(not illustrated) may be embedded or otherwise located on or within oneof the liners described herein. The RFID tag or chip may be used, forexample, to track manufacturing information related to the liner (e.g.,lot number, manufacturing date, manufacturing location, product type,etc.). The RFID tag or chip may also store information related when theliner or its associated sensor(s) have been installed or changed. TheRFID tag or chip may also contain information pertaining to a sensorthat is associated therewith. For example, some sensors may require acalibration curve or calibration parameters which can then be stored inthe RFID tag or chip.

While embodiments of the present invention have been shown anddescribed, various modifications may be made without departing from thescope of the present invention. For example, while the liners discussedherein have been described as being made of silicone other materialsbesides silicone may be used. As an alternative to UV-curable polymers,polymer materials that are curable at relatively low temperatures may beused. Other materials may also be envisioned that can work within thefluid monitoring assemblies described herein. For example, in someembodiments, the liners may be formed from a thermoplastic elastomer(TPE) or a thermoplastic rubber (TPR). For silicone, the liners may beunreinforced, reinforced, or braided silicon in some alternativeembodiments. The invention, therefore, should not be limited, except tothe following claims, and their equivalents.

1-30. (canceled)
 31. A fluid monitoring assembly comprising: a segmentof compressible unreinforced silicone tubing comprising a wall defininga lumen through which the fluid passes, the segment having a nipple thatprojects outwardly therefrom; a housing having first and second portionsconnected to one another at a hinge, the housing defining an interiorportion configured to hold the segment of compressible unreinforcedsilicone tubing; a pressure sensor having a pressure sensing end incontact with an exterior portion of the nipple and configured to measurethe pressure of fluid contained in the lumen of the compressibleunreinforced silicone tubing, wherein the pressure sensor is secured inone of the first and second portions of the housing; and a fastenerconfigured to hold the first and second portions in a closed state. 32.The fluid monitoring assembly of claim 31, wherein the housing comprisesa metal.
 33. The fluid monitoring assembly of claim 31, wherein thehousing comprises a polymer.
 34. The fluid monitoring assembly of claim31, wherein the pressure sensing end is in contact with a portion of thenipple having a reduced thickness.
 35. The fluid monitoring assembly ofclaim 31, wherein the pressure sensing end is in contact with a portionof the nipple having an increased thickness.
 36. The fluid monitoringassembly of claim 31, further comprising at least one pinch valvemounted in the housing and configured to selectively pinch the segmentof compressible unreinforced silicone tubing.
 37. The fluid monitoringassembly of claim 31, the fastener comprises a knob and locking arm. 38.The fluid monitoring assembly of claim 31, wherein the segment ofcompressible unreinforced silicone tubing comprises a common segment andone or more branch segments.
 39. The fluid monitoring assembly of claim31, wherein the pressure sensor is removable from the housing.
 40. Thefluid monitoring assembly of claim 39, wherein the pressure sensorcomprises threads that engage with corresponding threads in the housing.41. The fluid monitoring assembly of claim 31, further comprising one ormore additional non-pressure sensor sensors disposed on or in thehousing.
 42. The fluid monitoring assembly of claim 41, wherein the oneor more additional sensors comprises at least one of a conductivitysensor, a temperature sensor, a turbidity sensor, and a pH sensor. 43.The fluid monitoring assembly of claim 31, further comprising a RFidentification tag disposed on or within the compressible unreinforcedsilicone tubing.
 44. The fluid monitoring assembly of claim 31, whereinthe housing terminates in one or more flanges.